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Trial · Observational

CompletedPhase not statedRegistry data

Liraglutide and Cardio-Metabolic Risk Markers

NCTNCT01715428 (opens ClinicalTrials.gov in a new tab)Other idLIRAGLUTIDE UNIPA
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
300 participants (actual)
Sponsor
University of Palermo · Other
Design
Not stated
Countries
1 country

Italy

Start
Jun 2012
Primary completion
Dec 2015
Completion
Dec 2015
First posted
29 Oct 2012 (estimated)
Last update posted
22 Nov 2017
Conditions
Type-2 Diabetes

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20122013201420152016
  1. Ph –

    Liraglutide and Cardio-Metabolic Risk Markers

    NCT01715428

    Jun 2012 to Dec 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Incretin-based therapies have shown significant effects beyond those on glucose metabolism. We aim in the present study to evaluate the effects of liraglutide on several cardio-metabolic risk markers.

Arms1

  • Other

    Liraglutide

    administration of liraglutide at 1.2 mg/daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. carotid intima-media thickness

    Time frame · every four months for a total period of 2 years

    Registry description

    carotid intima-media thickness will be assessed by doppler ultrasonography

Secondary outcomes(3)

  1. changes in oxidative stress markers

    Time frame · after 2 months of therapy

    Registry description

    Serum LOOH levels were evaluated following the oxidation of Fe2+ to Fe3+ in the presence of xylenol orange at 560 nm. Levels of GSH were measured in serum using a spectrophotometric assay based on the reaction of thiol groups with 2,2-dithio-bis-nitrobenzoic acid, while the production of ROS was assessed using fluorescent probe dihydroethidium staining (Sigma).

  2. changes in plasma ghrelin concentrations and heat-shock proteins

    Time frame · after 2 months of therapy

    Registry description

    plasma ghrelin concentrations and heat shock protein 60 were measured by ELISA

  3. changes in atherogenic lipoproteins

    Time frame · after 2 and after 4 months of therapy

    Registry description

    the full LDL subclass profile (from larger and less atherogenic LDL-1 and LDL-2, to smaller denser LDL-3 to LDL-7) was assessed by gel electrophoresis (Lipoprint, Quantimetrix, USA)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies6

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Clinical trial · 2016

10 results

Liraglutide improves metabolic parameters and carotid intima-media thickness in diabetic patients with the metabolic syndrome: an 18-month prospective study.

Rizzo et al. 2016Cardiovascular diabetologycited by 114

PMID 27912784PMC5135832DOI 10.1186/s12933-016-0480-8PUB-27912784

CC BY10 results
Download PDFSee results (10)

Indexing hint: Clinical trial · 2015

6 results

Liraglutide reduces oxidative stress and restores heme oxygenase-1 and ghrelin levels in patients with type 2 diabetes: a prospective pilot study.

Rizzo et al. 2015The Journal of clinical endocrinology and metabolismcited by 93

PMID 25393640PMC4318909DOI 10.1210/jc.2014-2291PUB-25393640

Rights unknown6 results
Source linkSee results (6)

Indexing hint: Clinical trial · 2015

6 results

Liraglutide improves carotid intima-media thickness in patients with type 2 diabetes and non-alcoholic fatty liver disease: an 8-month prospective pilot study.

Rizvi et al. 2015Expert opinion on biological therapycited by 38

PMID 26195184DOI 10.1517/14712598.2015.1067299PUB-26195184

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Clinical trial · 2014

8 results

Liraglutide decreases carotid intima-media thickness in patients with type 2 diabetes: 8-month prospective pilot study.

Rizzo et al. 2014Cardiovascular diabetologycited by 95

PMID 24559258PMC3948058DOI 10.1186/1475-2840-13-49PUB-24559258

CC BY8 results
Download PDFSee results (8)

More studies

2 studies on this page

PubMed tag: none · 2022

Liraglutide Improved Cardiometabolic Parameters More in Obese than in Non-obese Patients with Type 2 Diabetes: A Real-World 18-Month Prospective Study.

Nikolic et al. 2022Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 30

PMID 35167051PMC8853434DOI 10.1007/s13300-022-01217-zPUB-35167051

Free to read · publisher termsCC BY-NC
Read at source

PubMed tag: none · 2021

Liraglutide Reduces Carotid Intima-Media Thickness by Reducing Small Dense Low-Density Lipoproteins in a Real-World Setting of Patients with Type 2 Diabetes: A Novel Anti-Atherogenic Effect.

Nikolic et al. 2021Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 62

PMID 33210276PMC7843804DOI 10.1007/s13300-020-00962-3PUB-33210276

Free to read · publisher termsCC BY-NC
Read at source

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: \- patients with a diagnosis of type-2 diabetes Exclusion Criteria: \- severe hepatic or renal diseases

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